Virtual Reality Mindfulness Meditation for ACL Injury

Overseen By Shelby E Baez, Ph.D., ATC

Age: < 65

Sex: Female

Trial Phase: Academic

Sponsor: University of North Carolina, Chapel Hill

Must not be taking: CNS medications

Disqualifiers: Male, Neurological conditions, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

48 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how virtual reality mindfulness meditation can aid women recovering from ACL surgery. Researchers aim to determine if this treatment reduces injury-related fear, improves jump-landing, and boosts brain activity. Participants will either engage in virtual reality meditation or participate in a similar activity without meditation (Virtual Reality Sham). Women who injured their knee playing sports and experience ongoing fear or jump-landing issues may be suitable for this trial. As an unphased trial, this study provides a unique opportunity to explore innovative recovery methods and contribute to groundbreaking research.

Will I have to stop taking my current medications?

The trial requires that participants not be on any medication that affects the central nervous system.

What prior data suggests that virtual reality mindfulness meditation is safe for ACL injury recovery?

Research has shown that Virtual Reality Mindfulness Meditation is generally safe for most people. Some users might experience mild side effects like dizziness or nausea, often called "VR sickness," because the virtual reality experience can affect the part of the ear that helps with balance. These effects are usually mild and resolve quickly. Most studies indicate that people handle this treatment well. Notably, Virtual Reality Mindfulness Meditation has proven effective in pain relief and stress reduction, which can benefit those recovering from an ACL injury. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Virtual Reality Mindfulness Meditation for ACL injuries because it introduces a unique method to enhance recovery through mindfulness. Unlike traditional physical therapy programs, this approach leverages virtual reality technology to guide patients through mindfulness meditation, which can help decrease rumination and improve focus on the present moment. By using VR, this treatment not only simplifies the process for patients and clinicians but also enhances the effectiveness of mindfulness states compared to conventional methods. This innovative delivery method could potentially make psychological interventions more accessible and effective, providing a new dimension to ACL injury rehabilitation.

What evidence suggests that virtual reality mindfulness meditation is effective for ACL injury recovery?

Research has shown that virtual reality mindfulness meditation (VRMM), which participants in this trial may receive, can aid women in recovering from ACL surgery by reducing their fear of reinjury and enhancing movement. A case report suggested that VRMM might improve recovery for patients after ACL reconstruction. Studies have found that virtual reality therapy can lessen pain and improve knee function and movement. Notably, VRMM has been shown to help people achieve mindfulness more effectively than traditional methods. These findings suggest that VRMM could be beneficial for better recovery after ACL injuries. Meanwhile, participants in the VR Sham Group will experience a virtual environment without the mindfulness meditation component. ^{1 4 5 6 7}

Who Is on the Research Team?

Shelby E Baez, Ph.D., ATC

Principal Investigator

UNC-Chapel Hill

Are You a Good Fit for This Trial?

This trial is for females aged 14-25 who had left-side ACL reconstruction surgery 1 to 5 years ago, are right-hand dominant, and injured their knee in sports. They must have MRI compliance, specific levels of fear related to movement (measured by a special scale), and poor jump-landing patterns. Excluded are males, those with recent concussions or CNS medications, claustrophobia, metal implants that can't be removed, under drug influence or pregnant.

Inclusion Criteria

Injured their knee playing or training for sports (recreational or organized)

I have had ACL reconstruction surgery on my left knee.

Have self-reported levels of fear on the Tampa Scale of Kinesiophobia-11

Exclusion Criteria

I have a neurological condition like epilepsy.

Presence of metal fragments, pins, plates, or clips, shrapnel, permanent makeup, body piercings that cannot be removed, surgical implants, or orthodontics that cannot be removed

Pregnancy or suspicion of pregnancy

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo 8 weeks of virtual reality mindfulness meditation or sham intervention along with an advanced neuromuscular training program

8 weeks

Weekly sessions

Follow-up

Participants are monitored for changes in injury-related fear, jump-landing movement patterns, and brain activity

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Virtual Reality Mindfulness Meditation
• Virtual Reality Sham

Trial Overview The study tests if virtual reality mindfulness meditation helps reduce injury-related fear, improves jump-landing movements and brain activity after ACL surgery compared to a sham VR experience. Participants will be divided into two groups: one experiencing the meditation VR and the other a fake version.

How Is the Trial Designed?

Group I: VR Mindfulness Meditation Group Experimental Treatment 1 Intervention

Participants will complete 8-weeks of virtual reality mindfulness meditation and an advanced neuromuscular training program. Mindfulness meditation is the practice of sustaining attention on the body, breath, or sensations in any given moment and allows for the self-regulation of attention by decreasing rumination about past or future events. During the practice of mindfulness meditation, the individual is aware of all incoming thoughts and feelings, but rather than reacting to them, the individual accepts them. Virtual reality mindfulness meditation has been demonstrated to be superior in inducing mindfulness states when compared to traditional mindfulness meditation. Use of a virtual reality system to implement mindfulness meditation not only decreases the barrier of time to implement psychological interventions, but also improves the clinician's confidence in implementing the intervention as the virtual reality system guides the patient through the mindfulness meditation process.

Group II: VR Sham Group Placebo Group 1 Intervention

Participants will complete 8-weeks of virtual reality sham and an advanced neuromuscular training program. Participants will be immersed in a virtual environment but will not receive the mindfulness meditation.

Virtual Reality Mindfulness Meditation is already approved in United States for the following indications:

Approved in United States as Virtual Reality Mindfulness Meditation for:

• Reduction of injury-related fear after ACL reconstruction
• Improvement of jump-landing movement patterns after ACL reconstruction
• Improvement of brain activity after ACL reconstruction

Who Is Running the Clinical Trial?

University of North Carolina, Chapel Hill

Lead Sponsor

Trials

1,588

Recruited

4,364,000+

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Collaborator

Trials

508

Recruited

1,090,000+

Published Research Related to This Trial

In a randomized controlled trial involving 20 first-time sternotomy patients, immersive virtual reality (VR) treatment significantly reduced anxiety levels compared to a tablet-based control, with VR users reporting feeling calmer and less tense (P<0.05).

The study demonstrates that VR is an effective nonpharmacologic method for alleviating preoperative anxiety in adults undergoing cardiac surgery, highlighting its potential utility in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Use of Virtual Reality to Reduce Preoperative Anxiety in First-Time Sternotomy Patients: A Randomized Controlled Pilot Trial. Hendricks, TM., Gutierrez, CN., Stulak, JM., et al.[2020]

In a pilot study with 47 healthy participants, both immersive virtual reality (VR) mindfulness and computer-based mindfulness meditation effectively reduced negative emotions, but there were no significant differences in mood improvement between the two methods.

The study found that using VR did not cause simulator sickness, indicating that it is a safe and viable method for delivering mindfulness interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immersive virtual reality or computerised mindfulness meditation for improving mood? Preliminary efficacy from a pilot randomised trial. Poetar, CR., Bradley, N., Voinescu, A.[2023]

Virtual reality (VR) mindfulness applications show potential benefits for managing chronic pain, including improvements in both physical and mental health, based on a review of seven studies.

However, the effectiveness of these applications is limited by weak study designs and small sample sizes, indicating a need for more rigorous research to validate their impact on health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual Reality-Based Mindfulness for Chronic Pain Management: A Scoping Review. O'Connor, S., Mayne, A., Hood, B.[2022]

In a pilot study involving 64 patients with psychosis, virtual reality-based mindfulness (VBM) showed some positive effects, such as increased decentering and reduced preoccupation with delusions, although it did not significantly outperform a VR control group.

While VBM was generally safe with mild VR sickness reported, it did not demonstrate a clear advantage in reducing psychiatric symptoms compared to the control, indicating that further research is needed to explore its efficacy in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects and safety of virtual reality-based mindfulness in patients with psychosis: a randomized controlled pilot study. Lee, BM., Kim, SW., Lee, BJ., et al.[2023]

A pilot study involving 19 older adults (aged 60+) demonstrated that a 10-minute virtual reality (VR) meditation program significantly reduced knee pain intensity both during and after the session, with effects lasting up to 24-48 hours.

The VR meditation not only alleviated pain but also improved participants' mood and daily functioning, indicating that it is a feasible and effective nonpharmacological treatment for chronic knee pain in older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The feasibility and effectiveness of virtual reality meditation on reducing chronic pain for older adults with knee osteoarthritis. Sarkar, TD., Edwards, RR., Baker, N.[2022]

In a study of 96 young adults, those who practiced virtual reality (VR)-guided meditation reported higher positive affect and greater satisfaction compared to non-VR meditation, especially when VR was done first.

Participants with higher PTSD symptoms experienced more distress during both types of meditation, suggesting that while VR may enhance meditation experiences, individuals with PTSD may need additional support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Meditating in virtual reality: Proof-of-concept intervention for posttraumatic stress. Mistry, D., Zhu, J., Tremblay, P., et al.[2021]

A study involving 20 patients with spinal cord injury showed that combining virtual reality (VR) training with conventional rehabilitation significantly improved upper limb function compared to conventional therapy alone.

Participants in the VR group experienced notable enhancements in grip strength and overall upper extremity motor scores, indicating that VR can be a safe and effective addition to rehabilitation programs for improving upper limb function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Fully Immersive Virtual Reality Method for Upper Limb Rehabilitation in Spinal Cord Injury. Lim, DY., Hwang, DM., Cho, KH., et al.[2020]

The study demonstrated that Immersive Virtual Reality (VR) enhanced Dialectical Behavioral Therapy (DBT) Mindfulness skills training can help reduce negative emotions and anxiety in two patients with spinal cord injuries, with one patient showing significant reductions in ASD/PTSD symptoms after just one session.

Both patients found the VR experience enjoyable and were able to use the equipment with assistance, indicating the feasibility of this therapeutic approach for individuals with paralysis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Use of Virtual Reality to Facilitate Mindfulness Skills Training in Dialectical Behavioral Therapy for Spinal Cord Injury: A Case Study. Flores, A., Linehan, MM., Todd, SR., et al.[2020]

Patients who experienced a preoperative virtual reality (VR) session with 3D MRI models of their knee reported significantly lower anxiety levels compared to those who received standard information, as measured by the Amsterdam Preoperative Anxiety and Information Scale.

The VR group also showed higher satisfaction and lower stress levels postoperatively, indicating that VR can enhance the overall patient experience before and after arthroscopic knee surgery, although it did not impact pain or preparedness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Preoperative Virtual Reality Magnetic Resonance Imaging on Preoperative Anxiety in Patients Undergoing Arthroscopic Knee Surgery: A Randomized Controlled Study. Yang, JH., Ryu, JJ., Nam, E., et al.[2020]

A systematic review of 11 randomized controlled trials involving 892 adult patients found that virtual reality (VR) interventions significantly reduce preoperative anxiety, with VR exposure being particularly effective.

In addition to lowering anxiety, VR interventions also effectively reduced heart rate and blood pressure compared to traditional methods, although they did not significantly impact respiration rate.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of virtual reality in reducing preoperative anxiety in adults: A systematic review and meta-analysis. Gao, Y., Wang, N., Liu, N.[2023]

A case study demonstrated that immersive virtual reality (VR) significantly reduced pain intensity by 43% and anxiety by 43% during the removal of external fixator pins in a conscious patient, compared to standard care without VR.

Using VR as a non-pharmacologic analgesic not only improved patient satisfaction with pain management but also has the potential to lower opioid use and associated risks during outpatient orthopedic procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Case Report: Virtual Reality Analgesia in an Opioid Sparing Orthopedic Outpatient Clinic Setting: A Case Study. Firoozabadi, R., Elhaddad, M., Drever, S., et al.[2021]

A study involving 77 healthy volunteers demonstrated that a High-Tech VR helmet significantly reduced procedural pain more effectively than a Low-Tech VR helmet, with participants reporting up to 34% less worst pain and 46% less pain unpleasantness.

The High-Tech VR helmet also led to a higher percentage of participants experiencing clinically significant pain reduction (65% vs. 29% in the Low-Tech group), emphasizing the importance of VR technology quality in pain management during medical procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual reality helmet display quality influences the magnitude of virtual reality analgesia. Hoffman, HG., Seibel, EJ., Richards, TL., et al.[2022]

Citations

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Virtual Reality Mindfulness Meditation to Improve Patient- ... Conclusion: This case report demonstrates that VRMM may effectively mitigate poor patient outcomes post-ACLR. These findings underscore the potential of VRMM as ...

2. withpower.com withpower.com/trial/phase-anterior-cruciate-ligament-injury-8-2022-0523b

Virtual Reality Mindfulness Meditation for ACL Injury This trial tests if using virtual reality for mindfulness meditation can help women who had ACL surgery reduce their fear of injury, improve their movements ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39302094/

Virtual reality-based therapy after anterior cruciate ligament ... Virtual reality-based therapy after anterior cruciate ligament injury effectively reduces pain and improves knee function, movement patterns, ...

4. clinicaltrial.be clinicaltrial.be/fr/details/15023?per_page=100&only_recruiting=0&only_eligible=0&only_active=0

Virtual Reality Mindfulness Meditation After ACL Reconstr... Injury-related fear after anterior cruciate ligament (ACL) injury significantly contributes to decreased return to sport, decreased physical ...

5. ctv.veeva.com ctv.veeva.com/study/virtual-reality-mindfulness-meditation-after-acl-reconstruction

Virtual Reality Mindfulness Meditation After ACL Reconstruction Virtual reality mindfulness meditation has been demonstrated to be superior in inducing mindfulness states when compared to traditional ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05592782

Study Details | NCT05592782 | VR Mindfulness Study This is an exploratory study investigating the use of virtual reality-based guided mindfulness meditation in improving pain, stress, and mood within various ...

7. unc.edu unc.edu/posts/2024/06/12/vr-may-help-athletes-recover-from-acl-injuries/

VR may help athletes recover from ACL injuries She and her team use psychological methods to help athletes return to sports, reduce the risk of secondary injury and improve knee joint health.